(30 days)
The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") is intended to assist in the accurate control of Intuitive Surgical" Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
This special 510(k) is being submitted for a minor labeling change / clarification on the da Vinci® Surgical System. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System or the Guidant Flex 10 ablation probe and Microwave Ablation System. The only change is an updated indication statement and addendum user manual sheet for the da Vinci® Surgical System.
The da Vinci® Surgical System consists of two integrated sub-systems as follows:
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
The provided 510(k) summary (K043153) describes a "Special 510(k)" for a minor labeling change/clarification for the Intuitive Surgical® da Vinci® Surgical System. Crucially, this submission explicitly states that there are no changes in the device's design, technology, materials, manufacturing, performance, specifications, and method of use.
Therefore, there is no new study or performance data presented in this specific 510(k) to prove the device meets acceptance criteria related to its performance. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices (K990144, K002489, K011002, K013416, K021036, K022574, K040237 for the da Vinci® system itself, and K013946, K041340 for the Guidant Microwave Ablation System).
Here's an analysis based on the document's content:
1. Table of acceptance criteria and the reported device performance:
Since this is a special 510(k) for a labeling change, no new specific performance acceptance criteria or reported device performance for the device itself is presented. The document asserts that "design analysis and comparison, as well as bench testing, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and that design output meets the design input requirements." However, the exact acceptance criteria for these past tests are not detailed in this document.
2. Sample size used for the test set and the data provenance:
Not applicable. No new test set data is presented for performance evaluation of the device. The "bench testing" mentioned is to confirm substantial equivalence, not to demonstrate new performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set requiring expert ground truth is described.
4. Adjudication method for the test set:
Not applicable. No new test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI/CAD device for image interpretation, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical system with human-in-the-loop control, not a standalone algorithm.
7. The type of ground truth used:
Not applicable. No new performance study requiring ground truth is described in this document. For previous clearances, the ground truth would have been established through a combination of engineering specifications, clinical outcomes, and expert assessment for safety and effectiveness in surgical procedures.
8. The sample size for the training set:
Not applicable. This document pertains to a labeling change for an existing device, not the development or training of a new algorithm.
9. How the ground truth for the training set was established:
Not applicable.
In summary, for K043153:
The "acceptance criteria" for this specific submission relate to the administrative requirements of a Special 510(k) – specifically, demonstrating that the labeling update and the intended use clarification do not alter the fundamental safety and effectiveness of the device as previously cleared. The "study that proves the device meets the acceptance criteria" is the assertion of substantial equivalence to previously cleared predicate devices and the internal checks (design analysis and comparison, bench testing) to confirm that the labeling change has no impact on the underlying device performance. The performance of the da Vinci® Surgical System itself was established in prior 510(k) submissions, which are not detailed in this document.
{0}------------------------------------------------
DEC 1 5 2004
Section II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K043153
| Date | December 7, 2004 |
|---|---|
| Submitter | Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Mike YramateguiDirector, Regulatory AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390e-mail: mike.yramategui@intusurg.com |
| SubjectDevice | Name: Intuitive Surgical® da Vinci® Surgical System and EndoscopicInstrumentsClassification Name: System, Surgical, Computer Controlled Instrument(21 CFR 876.1500)Common Name: Endoscopic Instrument Control System, EndoscopicInstruments and Accessories |
| PredicateDevices | Intuitive Surgical® da Vinci® Surgical System and EndoscopicInstruments (legally marketed under K990144 / K002489 / K011002 /K013416 / K021036 / K022574 / K040237); Guidant MicrowaveAblation System and Flex 10 Accessory (legally marketed underK013946 / K041340) |
| DeviceDescription | This special 510(k) is being submitted for a minor labeling change /clarification on the da Vinci® Surgical System. There are no changes inthe design, technology, materials, manufacturing, performance,specifications, and method of use for the da Vinci Surgical System or theGuidant Flex 10 ablation probe and Microwave Ablation System. Theonly change is an updated indication statement and addendum usermanual sheet for the da Vinci® Surgical System. |
The da Vinci® Surgical System consists of two integrated sub-systems as
{1}------------------------------------------------
K043i53 2/3
follows:
Device Description (continued)
Intuitive Surgical® Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC. which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.
Intuitive Surgical® Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci® Surgical System, also known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite™ Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.
- The Intuitive Surgical® Endoscopic Instrument Control System is Intended Use intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation. electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
{2}------------------------------------------------
| Comparison toPredicateDevice | There are no changes in the design, technology, materials,manufacturing, performance, specifications, and method of use for the daVinci® Surgical System or the Guidant Flex 10 probe and MicrowaveAblation System. The only difference is an updated indication statementthat provides a clarification of tasks that can be performed with the daVinci Surgical System; and an addendum instruction sheet that providesoperational information for use of the da Vinci® Surgical System with theGuidant Flex 10 Probe and Microwave Ablation System. The use of theda Vinci Surgical System to deliver and place the Flex 10 probe isequivalent to using conventional minimally invasive surgicalinstruments. This change does not impact the operational characteristicsor change the intended use of either device. |
|---|---|
| TechnologicalCharacteristics | The technological characteristics of the subject devices are the same asfor the predicate devices. |
| PerformanceData | Design analysis and comparison, as well as bench testing, has beenconducted to confirm that basic functional characteristicsaresubstantially equivalent to the predicate devices cited, and that designoutput meets the design input requirements. |
| Conclusion | Based upon the technical information, intended use, and performanceinformation provided in this pre-market notification, the da Vinci®Surgical System described herein has been shown to be substantiallyequivalent to current legally marketed predicate devices, and the resultsof the design control process confirm that the design output meets thedesign input requirements. |
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086
Re: K043153
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System and Endoscopic Instruments
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: November 12, 2004 Received: November 15, 2004
Dear Mr. Yramategui:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Mr. Michael H. Yramategui
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K043153
Device Name: Intuitive Surgical" Endoscopic Instrument Control System and Endoscopic Instruments
Indications For Use:
The Intuitive Surgical" Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci System") is intended to assist in the accurate control of Intuitive Surgical" Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
Page 1 of ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
510(k) Number K043153
Intuitive Surgical® da Vinci® Surgical System - Labeling Update / Clarification
SPECIAL 510(k) Section III, Page 1 of 1
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.